Description
Indications
Treatment of Thrombocytopenia in Patients with Chronic Immune Thrombocytopenia (ITP): Avapag is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Pharmacology
Pharmacodynamics: Platelet Response: Avatrombopag resulted in dose- and exposure-depen- dent elevations in platelet counts in adults. The onset of the platelet count increase was observed within 3 to 5 days of the start of a 5-day treatment course, with peak effect observed after 10 to 13 days. Subsequently, platelet counts decreased gradually, returning to near baseline values after 35 days.
Pharmacodynamics: Cardiac Electrophysiology: At exposures similar to that achieved at the 40 mg and 60 mg dose, Avatrombopag did not prolong the QT interval to any clinically relevant extent. Mean QTc prolongation effects >20 ms are not anticipated with the highest recommended therapeutic dosing regimen based on analysis of data from the pooled clinical trials in patients.
Dosage & Administration
- Platelet count less than 40X109/L: 60 mg (3 tablets) for 5 days
- Platelet count 40 to less than 50X109/L: 40 mg (2 tablets) for 5 days
Recommended Dosage for Patients with Chronic Immune Thrombocytopenia: Initial Dose Regimen: Begin Avatrombopag at a starting dose of 20mg (1tablet) once daily with food. Avatrombopag Dose Adjustments for Patients with Chronic Immune Thrombocytopenia-
Less than 50 after at least 2 weeks of Avatrombopag x 109/L: Increase One Dose Level. Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments.
Between 200 and 400 x 109/L: Decrease One Dose Level. Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments.
Greater than 400 x 109/L: Stop Avatrombopag. Increase platelet monitoring to twice weekly. When platelet count is less than 150 x10 9 /L, decrease One Dose Level per Table 3 and reinitiate therapy.
Less than 50 after 4 weeks of Avatrombopag 40 mg once daily x 109/L: Discontinue Avatrombopag.
Greater than 400 after 2 weeks of Avatrombopag 20 mg weekly x 109/L: Discontinue Avatrombopag.
Or, as directed by the registered physician.
Interaction
Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4: Concomitant use with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 increases Avapag AUC, which may increase the risk of Avapag toxicities. Reduce the starting dosage of Avapag when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4.
Moderate or Strong Dual Inducers of CYP2C9 and CYP3A4: Concomitant use with a moderate or strong dual inducer of CYP2C9 and CYP3A4 decreases Avapag AUC, which may reduce Avapag efficacy.
Increase the recommended starting dosage of Avapag when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4.





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